无细胞百白破联合疫苗安全性和免疫原性研究

STUDY ON THE IMMUNOGENICITY AND SAFETY OF DTaP

[目的]评价长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗的安全性和免疫原性。[方法]在江苏省连云港市赣榆县选择3~5月龄、未接种过百白破联合疫苗、无百日咳白喉破伤风疾病史的足月健康儿童进行临床研究,采用随机、双盲、同类疫苗平行对照设计,将观察对象按3︰2的比例随机分别接受观察疫苗和对照疫苗的接种。在观察期内对接种对象进行安全性观察,接种前后采集血清样本,进行免疫原性的观察。[结果]受试者全身中度发热反应发生率为1.62%（15/924）,没有出现全身严重及以上反应。未出现中度以上局部反应。免疫原性结果表明：受试者破伤风抗毒素阳转率为100.00%;白喉抗毒素阳转率为98.05%;抗百日咳毒素抗体阳转率为87.99%,抗丝状血凝素抗体阳转率为93.18%。[结论]该疫苗接种后具有低反应性和较好的免疫原性。

[Objective]To evaluate the immunogenicity and safety of the DTaP manufactured by ChangChun Changsheng Life Sciences Limited（CCLSL）.[Methods]525 healthy infants aged 3-5 months in Ganyu County of Lianyungang City and without incubation of DTaP vaccine and relevant diseases were selected in this study.Adopting random,double blind and parallel control design,in proportion of 3 to 2,the selected infants were assigned to observation group（inoculation with DTaP manufactured by CCLSL）and control group（inoculation with DTaP manufactured by Wuhan Institue of Biological Products）.During the observation period,the immunogenicity and safety of the vaccine were observed.[Results]The rate of moderate fever adverse reaction was 1.62%.There were no severe systemic and moderate local adverse reactions.Immunogenicity results showed the antibody positive sero-conversion rates for tetanus and diphtheria were 100% and 98.05% respectively,the antibody positive sero-conversion rates for PT and FHA were 87.99% and 93.18% respectively.[Conclusions]The DTaP manufactured by CCLSL has better immunogenicity and hypoergy.